Chemika’s expansive laboratory space in Western Sydney is equipped to carry out a variety of routine and non-routine analysis for the pharmaceutical industry.
Chemika is located in a purpose refit facility in Girraween in Western Sydney. The chemical testing laboratory was opened in 2012 with the aim of building the best laboratory in Australia for the purpose of analysis of therapeutic goods.
The laboratory area allows ample space for accommodation of current and future staff. Areas are arranged for good lines of sight with dedicated areas for specific activities, including a “yellow” room for working with light sensitive materials and staff write up areas. The laboratory features a high level of security with swipe card access for staff and excellent separation between the more public areas of the facility (such as reception and the conference room) and the laboratory area.
Data integrity principles have led to the evolution of laboratory equipment and layout, with secure server areas and server based software reducing the need for analysts to process data and operate instruments from the laboratory area.
In 2021 Chemika achieved full compliance with CFR21 part 11 including implementation of GAMP5 procedures.
In many cases, this required replacement of equipment which could not be brought into compliance with current requirements. Investment has been substantial and has resulted not only in enhanced regulatory compliance but also significant improvements in efficiency.
Equipment is as follows:
- AAS, ICP-OES and ICP-MS including halide generation methods on the AAS
- Headspace and liquid injection GC, with ECD, TCD and FID. Capillary and packed columns. Configured with both liquid and headspace injection.
- GCMS configured with liquid and headspace injection.
- HPLC with detection by photo diode array, UV/Vis., refractive index, fluorescence and conductivity. Ability to perform post column derivatisation.
- Karl Fischer water analysis, both by wet chemical titration and coulometric methods.
- Vacuum oven.
- Dissolution testing. USP and BP apparatus 1 and 2 are available.
- Disintegration testing.
- Friability testing.
- Hardness and dimensions of tablets.
- Nitrogen using automated Kjeldahl distillation apparatus.
- Sealed microwave digestion systems.
- Auto-titration with several detection options, including turbidometric.
- Viscosity by Brookfield using conventional or helipath spindles, and by U-tube.
- FTIR – qualitative and quantitative, sample preparation as ATR, KBr disc, paraffin mull or liquid.
- UV-Vis. Spectrometer.
- TOC for purified waters. Analysis run each Thursday.
- Polarimetry for identification and assay.
- Photostability testing (ICH protocol).
- ISE – fluoride, nitrate and ammonia routinely undertaken.
- Autoclave for sample preparation (eg testing of glass vials).
- Particle size analysis.
- Refractive index.
- Melting point using USP apparatus 1 or 2.